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临床试验/NCT04589767
NCT04589767已完成不适用

Validation Study of the "CORNELL ASSESSMENT PEDIATRIC DELIRIUM" (CAPD)" Scale in Italian Language

Azienda Ospedaliera di Padova1 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2020年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
70
试验地点
1
主要终点
inter-evaluator agreement

研究概览

简要总结

70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

详细描述

The psychometric validation study will take place in the PICU of the Hospital of Padua. CAPD translation and cultural adaptation was developed within the Pediatric Cardiac Surgery Intensive Care Unit of the Federico II Polyclinic.

In this study we aim to perform the psychometric validation. 70 children (based on the inclusion and exclusion criteria described above) admitted in PICU will be daily assessed by two nurses (inter-evaluator agreement) using the Italian version of CAPD scale administered twice at a distance of 2 minutes (intra-evaluator agreement).

The score will be recorded in a data collection card, all the cards will be collected and then analyzed.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • PICU admission
  • Comfort Behavioral Score > 11

排除标准

  • use of neuromuscular blocking agents at the moment of CAPD evaluation
  • Comfort Behavioral Score < 11

结局指标

主要结局

inter-evaluator agreement

时间窗: 1 hour during PICU stay

CAPD evaluation by two operators

intra-evaluator agreement

时间窗: 2 minutes during PICU stay

CAPD evaluation by two operators

次要结局

未报告次要终点

研究者

发起方
Azienda Ospedaliera di Padova
申办方类型
Other
责任方
Principal Investigator
主要研究者

angela amigoni

MD

Azienda Ospedaliera di Padova

研究点 (1)

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